1. Field of the Invention
This invention relates in general to certain new and useful improvements in algorithm and methods for enabling the handling and administration of radioactive pharmaceuticals, and more particularly, to an algorithm, a program used therein, and an associated method which allows for the control of radioactive pharmaceuticals and the areas in which they are used and for a system and method for maintaining records and generating reports, and handling the dispensing of radioactive pharmaceuticals.
2. Brief Description of Related Art
In recent years, the field of nuclear medicine has relied more heavily upon the use of radioactive pharmaceuticals, primarily for diagnostic purposes, but for other treatment purposes as well. Generally, radioactive pharmaceuticals were introduced into a patient's blood stream, and allowed to be carried to one or more organs of the body which are to be investigated. In this way, it was possible to specifically locate tumors or other dysfunction causing conditions.
Also, in the recent past, it has been found that certain tumors, and other dysfunction causing conditions, will not become visually apparent from presently available diagnosing techniques, such as magnetic resonance imaging and computer tomography. However, it has been found that these conditions will become visually apparent when radioactive dies are lodged or introduced into the tumors and other tissue in which observation may be necessary. Due to the greater widespread use of radioactive pharmaceuticals, and the potential for radioactive hazard, both in the handling and in the disposition of waste materials, there has been a need for careful control over the use of such materials. In fact, in the United States, both the federal government and the various state governments have levied numerous regulations controlling the use and disposition of these radioactive materials.
The pharmaceutical houses which dispense these radioactive materials, are required to account for complete use of the radioactive material, including the handling of the waste resulting therefrom, and generate reports to those government agencies which are involved in the regulation thereof. The same holds true for the end users of these radioactive pharmaceuticals, as for example, the hospitals and the physicians and medical centers which are involved in the administration of these radioactive pharmaceuticals. These end users are typically involved in the business of providing medical care and administering for radioactive pharmaceuticals, and generating governmental reports becomes a very time consuming and, indeed, an expensive task.
This increasing widespread use of radioactive pharmaceutical materials has given rise to a number of radioactive pharmaceutical supply facilities which supply the end users, e.g., medical institutions, hospitals and physicians with these radioactive materials. These supply houses are frequently referred to as “pharmacies” and “radioactive drug pharmacies”. Some of the end users, such as hospitals, etc., were originally quite lax in control of the radioactive materials, and in the maintenance of data for generation of reports. Consequently, the U.S. federal government and the various state governments, at least in the United States, have enacted, and even tightened, regulations which require very accurate reporting on a periodic basis.
The federal government as well as several state governments, call for the reporting of the use of each aliquoted portion of radioactive material, including the use of handling materials such as gloves, storage tubes, scales, and the like. Thus, more specifically, reports must be made on the type of material used for each particular patient, the amounts used, the dates of use, and even how any remnant portions of the material were discarded. Moreover, reports must be made on the handling equipment which may have come into contact with radioactive materials, such as test tubes, beakers, and the like.
It may be appreciated that there are numerous details involving the complete handling of all radioactive material, and the equipment used in the handling of that material, and hence, reporting requirements are extensive and render the preparation of reports to be time consuming and hence, costly. In fact, depending upon the amount of radioactive material dispensed, the number of patients receiving these materials, and like factors, personnel are frequently exclusively devoted to gathering of information and preparation of such reports.
There have been attempts to use data processing techniques for storage of information. However, and heretofore, these data processing techniques generally rely upon the pure storage of information, without much attention being given to segregation of data for report preparation and auditing, and even for informational purpose by the user thereof.
There has been, at least, one attempt to provide a software program for gathering of data and generating reports for the handling and dispensing of radioactive materials. However, this attempt involves only the specific use of the materials offered by a single pharmaceutical facility. It is not capable of universal use with a variety of pharmaceutical materials and a variety of conditions not otherwise existing with this particular source of pharmaceutical materials. Moreover, the program is severely lacking, and still requires a substantial amount of personnel time in gathering of information and generating the necessary governmental reports.
One of the primary problems with the prior art software programs which have been generated for handling and dispensing of radioactive materials, is the fact that they were not particularly user-friendly. The operator of the system had to be fairly well experienced in dealing with computers in general, and in switching back and forth between subroutines in complex algorithms. As a simple example, if there were a menu page presented on the screen of a monitor, the operator would have to track the particular page involved, in order to examine details of a routine on that menu page. In many cases, the operator even had to go to additional menu screens in order to find the routine which was needed. Moreover, when the operator finished with one routine, the algorithm did not allow the operator to immediately return to the main screen, with a mere click of a pushbutton switch.
Another one of the problems inherent in the prior art system is that they were not readily adaptable to changing requirements. Thus, if a governmental agency required a new type of report or an altered report to be generated, this almost necessitated the need for a skilled programmer to input that instruction base necessary for an operator to use. Consequently, the prior art programs were severely lacking in many respects.
It can also be recognized that each medical institution has different operating procedures than others. Moreover, certain of the medical facilities have larger staffs than others, and hence, a greater capability of record keeping. Consequently, and inasmuch as the medical facilities would prefer to avoid substantial record keeping and the details associated with administering of these radioactive pharmaceuticals, each facility may prefer a somewhat different algorithm to track the use of radioactive pharmaceuticals. Therefore, there is a clear need for an algorithm and a program which operates a method for administering the radioactive pharmaceuticals, and for also generating the required governmental reports therefor.
There has therefore been a need for a system which will allow for the automatic retention of data, segregation of data according to specific functions and materials, and which will also generate reports based on the collected data, all on an automated basis. There has also been a need for a system of this type which could be universally applicable to the collection and segregation of data and generation of reports, based on the particular materials used and the functions which are necessary by a user of such system.
In addition to the foregoing, there has been a need for these end users, as well as the radioactive pharmaceutical companies, to maintain internal controls over the use and dispensing of radioactive pharmaceuticals, in order to insure for the health and the safety of those parties dealing directly with these pharmaceuticals. This need for control over the radioactive pharmaceuticals also involves an intended need for careful control and monitoring of the areas in which the pharmaceuticals are used, inasmuch as the latter can also become contaminated from the radioactive pharmaceuticals.
Furthermore, there has also been a need for an orderly and regulated manner in which an end users and a radioactive pharmaceutical company could maintain appropriate record keeping in order to insure the ordering of radioactive pharmaceuticals on a needed basis. It may be appreciated that in many cases, the pharmaceutical activity of a radioactive pharmaceutical can decrease rapidly, depending upon the half life of the radioactive material. Consequently, careful control over the ordering of the radioactive materials and dispensing must also be maintained.
There has been a further need for some method to allow for internal control over the use of radioactive pharmaceuticals, and also some method which allows for the control and ordering of radioactive pharmaceuticals and related materials timely in response to demand therefor.